According to the Medical Device Classification Catalog, SaMD is a software that has one or more medical purposes to accomplish the intended use without medical device hardware, and operates on a general operation platform.
SaMD includes universal software and specific software.
The universal software is based on universal data port and can be combined with multiple medical device products, e.g. PACS, central monitoring software, etc.
The specific software is based on universal and specific data port, and can be combined with a specific medical product, e.g. Holter data analysis software, imaging processing software for ophthalmological microscope, etc.
SaMD Clinical Exemptions
In the Classification Catalog, SaMD can be Class II and III; it cannot be Class I. Does that mean SaMD has to go through the expensive and time-consuming clinical trial?
No, clinical trial exemptions apply to some SaMDs. According to Medical Device Clinical Trial Exemption Catalog issued on September 30, 2018, 7 SaMDs are exempted from clinical trial:
- Medical image storage and transmission system Software
- Medical image processing software
- Data processing software
- Trace analysis software
- Allergen semi-quantitative analysis software
- Radiotherapy record and verification system software
- Radiotherapy contour delineation software
What if your software does not fall into the Exemption Catalog? Again, China classification is based on clinical indications instead of device type, which leaves space for negotiation with NMPA. You can give us your IFU and your home-country-approval documents so we will be able to determine the classification, clinical exemption status and regulatory pathway for you. info@ChinaMedDevice.com
For our comments on Medical Device Classification Catalog, please click HERE. For Clinical Exemption Catalog, please click HERE.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.
